Final Report

Analysis of Laboratory Capacity 

to Support U.S. EPA Chemical 

Testing Program Initiatives 

Prepared by: 

Economics, Policy, and Analysis Branch (7406M) 

Office of Pollution Prevention and Toxics 

U.S. Environmental Protection Agency 

1200 Pennsylvania Avenue NW 

Washington, DC 20460 

 

August 30, 2004 
CONTRIBUTORS

The EPA analyst responsible for this report was Lynne Blake-Hedges. Analytical and draft 

preparation support was provided by Eastern Research Group, Inc. under subcontract to Abt 

Associates Inc. under EPA Contract No. 68-W-02-077. 
TABLE OF CONTENTS (Continued) 

Page 

 ii

TABLE OF CONTENTS 

Page

1.0 INTRODUCTION .........................................................................................................1 

2.0 DEMAND FOR CHEMICAL TESTING SERVICES............................................................2 

2.1 HPV Testing in the United States ................................................................2 

2.2 HPV Testing in the European Union ...........................................................3 

2.3 OECD/ICCA HPV Testing Program ...........................................................4 

2.4 Comparison of U.S. and EU HPV Chemical Testing Programs..............................5 

2.5 Impact of the HPV Challenge and REACH on Chemical Testing Demand8 

2.6 U.S. Testing for Endocrine Disruption Potential...................................................11 

3.0 SUPPLY OF CHEMICAL TESTING SERVICES..............................................................17 

3.1 Contract Research Organizations...............................................................17 

3.2 Captive In-House Testing Labs .................................................................20 

3.3 Other Sources of Testing Capacity ............................................................21 

4.0 CURRENT INDUSTRY ISSUES....................................................................................21 

4.1 Issues Affecting Demand...........................................................................21 

4.2 Issues Affecting Supply .............................................................................23 

5.0 CONCLUSIONS.........................................................................................................28 

6.0 REFERENCES ...........................................................................................................30 
 1

 

1.0 INTRODUCTION

Under the authority of the Toxic Substances Control Act (TSCA), the U.S. Environmental 

Protection Agency (EPA) is authorized to request from industry certain data on the human health 

and ecological effects of commercially produced chemicals, if the Agency determines such test 

data is necessary to assist it in assessing the risks from such chemicals. In addition to such 

regulatory-driven activities, industry has agreed to collect and submit certain types of chemical 

testing data to EPA on a voluntary basis. 

In its planning and decisionmaking with respect to both regulatory and voluntary chemical 

testing initiatives, EPA wishes to be cognizant of the effects of such programs on industry. One 

question that has generated significant interest is whether sufficient laboratory capacity is 

available to satisfy the demand for chemical testing generated by such programs.1

The purpose of this document is to improve EPA’s understanding of the capacity of the chemical 

testing industry to respond to current and future testing initiatives. The report summarizes 

information on the current and potential future capacity in the industry to perform certain kinds 

of chemical tests in the United States, as well as overseas. Because the testing industry operates 

internationally, the report focuses not just on U.S. testing initiatives, but those elsewhere that 

also affect the global chemical industry, in particular the proposed expansion to the testing 

program in the European Union (see Section 2.2). 

In this report, the term “chemical testing industry” applies broadly to any organization that has 

the capability to use standard laboratory methods to determine the effects that a particular 

chemical may have on humans or the environment. These may include contract research 

organizations (CROs), whose primary line of business is analytical testing; in-house testing 

laboratories maintained by chemical companies or others (who may also do work for hire); as 

1

 A second and related question is whether such capacity is available at a reasonable price. This question, 

however, was not explicitly addressed in this report. 
 2

well as laboratories maintained and operated by academic or other institutions. The primary 

focus in this report is on CROs, who are likely to undertake the majority of the testing covered 

by this report, although Section 3 (supply of testing services) contains a discussion of captive, inhouse labs as well. 

This report was prepared using public information compiled for EPA about the chemical testing 

industry, discussions with EPA and other experts familiar with the industry, and information 

collected first hand from laboratories exhibiting at a major trade show in the spring of 2004. 

2.0 DEMAND FOR CHEMICAL TESTING SERVICES

Laboratories and industry observers contacted during the preparation of this report agreed that 

the primary driver for the chemical testing industry, presently at least, is the demand for testing 

in the biotechnology and pharmaceutical areas. Contracts with biotech and pharmaceutical firms 

to conduct product testing currently account for a majority of CRO and in-house testing activity, 

and such contracts were deemed most critical to the economic success or failure of a laboratory 

(Piccirillo 2003). As a general statement, therefore, the demand for testing generated by EPAmandated (i.e., TSCA) programs, as well as voluntary EPA testing programs, does not dominate 

the industry. 

It is important to note that activity levels in all testing areas can change, and some labs may be 

more dependent on some programs than other. To help understand trends in the marketplace, the 

sections below review several major chemical testing programs underway in the U.S., the EU, 

and other countries. 

2.1 HPV Testing in the United States 

In the U.S., one of the primary EPA testing initiatives is the “High Production Volume (HPV) 

Challenge” chemical testing program. Under the HPV Challenge, EPA has invited industry to 
 3

voluntarily sponsor the collection of a basic set of test data for the 2,089 chemicals produced or 

imported into the U.S. at volumes equal to or in excess of one million pounds. The HPV 

Challenge was initiated in response to findings that basic hazard data was unavailable for a 

substantial number of HPV chemicals. 

Under the program, initiated in 1998, any needed testing should be completed by 2004 and all 

data will be made available to the public by 2005 (U.S. EPA 2000). Individual chemicals that 

remain unsponsored may be evaluated by EPA as candidates for test rules under Section 4 of 

TSCA. 

The HPV Challenge uses a set of 15 testing endpoints defined by OECD’s “Screening 

Information Data Set” (SIDS). As conceived by the OECD, the “SIDS battery” of tests can be 

used by governments to conduct an initial assessment of the hazards and risks posed by HPV 

chemical substances, and prioritize HPV chemicals to identify those in need of more in-depth 

testing and assessment. More information on the SIDS testing protocols is presented below in 

Section 2.4. 

2.2 HPV Testing in the European Union 

The European Union (EU) operates a testing program for both new chemicals and existing 

chemicals produced at high volume, defined in the EU as 1,000 metric tons or greater (2.2 

million pounds) (European Chemicals Bureau 2004; Safepharm Laboratories 2003). Currently, it 

maintains dossiers on approximately 10,400 existing chemicals (European Chemicals Bureau 

2004). 

The EU’s proposed Registration, Evaluation and Authorisation of Chemicals (REACH) program 

would substantially expand the provisions of the existing chemicals program (Liikanen and 

Wallstöm 2003; Miller 2003; Synthetic Organic Chemical Manufacturers Association 2003; 

Squire & Sanders 2003). Under current draft guidelines, substances produced or imported in 
 4

annual quantities of 1,000 metric tons (2.2 million pounds) or more would need to be tested 

within three years; substances produced or imported at annual quantities of 100 to 1,000 metric 

tons (220,000 to 2.2 million pounds) would need to be tested within six years; and substances 

produced or imported at annual quantities of 1 to 100 tons (2,200 to 220,000 pounds) would need 

to be tested within 11 years. Because it extends coverage to lower volume chemicals, the 

REACH proposal encompasses far more chemicals than the U.S. HPV program—an estimated 

20,000 chemicals compared with the 2,089 HPV chemicals in the U.S. 

Table 1. Proposed EU Chemical Testing Program (REACH)

Threshold volume 

Metric tons* Pounds

Estimated Number of 

Chemicals

Time Frame to 

Complete Testing

1,000 or greater 2.2 million or greater 1,799 

+ 1,061 intermediates 

within 3 years 

between 100 and 1,000 between 220,000 and 2.2 

million 

1,645 within 6 years 

between 10 and 100 between 22,000 and 

220,000 

3,466 

between 1 and 10 between 2.2 and 22,000 11,711 

within 11 years 

Total chemicals covered 19,682 -- 

*Metric tons manufactured or imported to the EU on an annual basis. 

Source: Risk & Policy Analysts 2003. 

2.3 OECD/ICCA HPV Testing Program 

In 1998, the International Council of Chemical Associations (ICCA), representing the global 

chemistry industry, announced an effort to work with OECD to develop test data for 1,000 

priority OECD HPV chemicals (ICCA 2002). The program has a goal of completing SIDS 

testing and initial hazard assessments on these chemicals by the end of 2004. This program is 

based on a broad international collaboration of chemical manufacturers. Under the HPV 

Challenge, EPA is recognizing commitments made to complete testing under the ICCA initiative 
 5

(U.S. EPA 2004). While the bulk of the research is originating in Germany, Japan, the U.K., and 

the U.S., 20 other nations are also participating, (OECD 2004). 

2.4 Comparison of U.S. and EU HPV Chemical Testing Programs 

EPA’s HPV Challenge Program and the EU’s Existing Chemical Program involve a similar set 

of tests (U.S. EPA 2003c; European Chemicals Bureau 2003; Commission of the European 

Communities 2003; Piccirillo 2003). The EU REACH program, however, calls for several tiers 

of testing, with more intensive testing required for chemicals produced at relatively high volume 

and less intensive testing required for chemicals produced at relatively low volume. Table 2 

below provides a comparison between these two programs. 
 6

Table 2. Comparison of HPV and REACH Testing Programs

EU REACH Proposal — Tiered Testing Based on Annual Volume of Chemical Produced or Impor

1 to 10 metric tonnesa 10 to 100 metric tonnes 100 to 1,000 metric tonnes 1

EPA HPV

“Limited Set” (Described in Annex V)

“Base Set” (Described in Annex VI)

“Base Set + “Level 1” (Described in Annex VII)

“(

Estimated number of chemical substances being sponsored

2,089 11,711 + 1,061 intermediatesb 3,466b 1,645b. It is expected that some of 

these will ultimately be exempted from Level 1 testing. 

1

wo

Tests performed

Physical-Chemical DataC Melting point C Boiling point C Density (relative density) C Vapour pressure C Partition coefficient (noctanol/water) C Water solubility C pH value and pKa value C Oxidation-reduction potential C Adsorption/ desorption to soild

C Melting-point C Boiling-point C Relative density C Vapour pressure C Surface tension C Water solubility C Partition coefficient n-octanol/water C Flash-point C Flammability C Explosive properties C Self-ignition temperature C Oxidizing properties C Granulometry 

Same as in column to the left Tests described in the column to 

the left, plus: C Stability in organic solvents 

and identity of relevant degradation products 

C Dissociation constant C Viscosity 

S

Toxicological StudiesC Acute toxicity C Repeated dose toxicity C Developmental toxicity/ 

Teratogenicity 

C Experiences with human exposure 

C Skin irritation or skin corrosion C Eye irritation C Skin sensitization C Mutagenicity: In vitro gene mutation 

study in bacteria 

Tests described in the column to the left, plus:C Skin irritation; In vivo skin irritation C Eye irritation: In vivo eye irritation C Mutagenicity: In vitro cytogenicity 

study in mammalian cells; In vitro gene 

mutation study in mammalian cells 

C Acute toxicity: by oral route; by 

inhalation; by dermal route 

C Repeated dose toxicity: short-term 

repeated dose toxicity study (28 days) 

C Reproductive toxicity: screening for 

reproductive/ developmental toxicity; developmental toxicity study 

C Toxicokinetics 

Tests described in the column to the left, plus: C Repeated dose toxicity: shortterm repeated dose toxicity 

study (28 days); sub-chronic toxicity study (90 days) 

C Reproductive toxicity: 

developmental toxicity study (additional); two-generation reproductive toxicity study 

TpC 
 7

Environmental Fate and Pathways c

C Photodegradation C Stability in water (hydrolysis) C Monitoring data (environment) C Transport and distribution between 

environmental compartments including estimated environmental concentrations and distribution pathways 

C Biodegradation 

C Degradation: biotic; abiotic C Fate and behavior in the environment: 

adsorption/ desorption screening study 

C Degradation: biotic(additional); 

identification of degradation products 

C Fate and behavior in the 

environment: adsorption/ desorption (additional); bioconcentration in one aquatic species, preferably fish 

C C 

Ecotoxicological StudiesC Acute/prolonged toxicity to fish C Acute toxicity to aquatic 

invertebrates (daphnia) 

C Toxicity to aquatic plants e.g. algae C Chronic toxicity to aquatic 

invertebrates (daphnia) 

C Toxicity to terrestrial organisms C Avian dietary toxicity test C Avian reproduction test C Earthworms acute toxicity test C Terrestrial plants, growth test 

C Aquatic toxicity: Short-term toxicity 

testing on Daphnia

Tests described in the column to the left, plus:C Aquatic toxicity: Growth inhibition study 

on algae; Short-term toxicity testing on fish; Activated sludge respiration inhibition testing 

ests described in the column to the left, plus:C Aquatic toxicity: Long-term 

toxicity testing on Daphnia; Long-term toxicity testing on fish 

C Effects on terrestrial 

organisms: Short-term toxicity to earthworms; Effects on soil microorganisms; Short-term toxicity to plants 

TpC C C 

Sources: US. EPA 2003c, Commission of the European Communities 2003, Risk & Policy Analysts 2003.a Also required for isolated intermediates transported in quantities of greather than 1,000 tonnes per year bSee Risk & Policy Analysts 2003, p. 35 and 37. Figures do not include polymers.c EU documentation lists these tests under the category of “Ecotoxicological Studies” d This test may also be categorized under Environmental Fate and Pathways 
 8

 

2.5 Impact of the HPV Challenge and REACH on Chemical Testing Demand 

Testing demand to satisfy data needs for the HPV Challenge has been lower than initially 

expected because many of the data gaps identified in EPA’s HPV testing initiative have been 

filled using existing research, thereby avoiding the need for new testing. For example, 

Environmental Defense’s “HPV Tracker” tool indicates that, based on test plans filed through 

July 2004, no further testing is planned for 460 of 1,338 chemicals (34.4 percent) 

(Environmental Defense, 2004). 

EPA’s own analysis indicates the amount of new testing required may be even lower. Through 

August 2003, EPA had received and reviewed (but not necessarily approved) test plans covering 

approximately 790 HPV chemicals. Each test plan addresses the 15 SIDS endpoints, thus the 

test plans reviewed address a total of 11,850 endpoints. The reviewed test plans suggest that 

approximately 6,800 endpoints, or 45 percent of the total, can be satisfied with existing data (see 

Table 3). For another 50 percent, or 7,400 endpoints, data was submitted based on analogy, 

structure-activity relationship modeling, technical discussion, “read-across,” or computer and 

mathematical modeling. Sponsors plan to conduct actual new testing to fill data gaps for only the 

remaining 785 endpoints. This would represent just 6.5 percent of the endpoints required to 

fulfill the SIDS testing requirements for these 790 chemicals2 (U.S. EPA 2004b). 

 

2

 It is important to note that the test plans reviewed represent only 38 percent of all HPV chemicals. For the 

remaining chemicals it is not known whether existing data or modeling results will satisfy the testing requirements 

to the same degree. 
 9

 
 10

Table 3. Summary of Test Requirements for 790 Sponsored HPV Chemicalsa,b

Chemical Properties

Environmental Fate and 

Pathways Ecotoxicity 

Testing Status  Number of ChemicalsProposed for testing 25 38 15 73 89 9 60 32 5 47 57 68 1 7 37 Analogy, SAR, Estimation 290 299 372 444 365 583 343 414 634 363 405 450 8 232 358 Adequate existing data 325 385 320 242 307 122 361 141 80 344 292 234 0 532 383 Testing based on results of other category members 0 0 4 1 1 8 0 3 13 4 4 4 0 0 0 Reproductive and developmental testing will depend on results of repeat dose studies 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

Not applicable due to 

physical/chemical properties 150 68 79 29 28 68 25 200 57 32 32 34 781 19 11 

Not addressed in test plan 0 0 0 1 0 0 1 0 1 0 0 0 0 0 1 TOTAL 790 790 790 790 790 790 790 790 790 790 790 790 790 790 790 

aBased on EPA’s preliminary review of submitted test plans as of August 29, 2003. bThe columns show 19 endpoints, however only 15 must be completed to fulfill the SIDS dossier. For example: the transport and distribution test is o

genetic toxicity requirement using either in vivo or in vitro methods; and submitters may complete either the repeated dose toxicity test or a combinat

developmental toxicity testing. See U.S. EPA (2003c) for further details.